UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of 1 week continuous ingestion of drink containing plant extract. A-18001
Title of the study (Brief title)	Examination of 1 week continuous ingestion of drink containing plant extract. A-18001
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of plant extract on vascular function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin temperature before and after 1day drink ingestion.
Key secondary outcomes	Peripheral blood flow and subjective evaluation.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Drink containing plant extract (1 week continuous ingestion)->washout period->placebo drink not containing plant extract (1 week continuous ingestion)
Interventions/Control_2	Placebo drink not containing plant extract (1 week continuous ingestion)->washout period->Drink containing plant extract (1 week continuous ingestion)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Female
Key inclusion criteria	1.Healthy adults 2.Person whose estradiol cycle is stable between 28 and 32 days. 3.Person who is sensitive to cold. 4.Person who agrees not to ingest specified foods and supplements during the test period.
Key exclusion criteria	1.Person whose body math indexes are less than 18.5 or more than 25.0. 2.Person whose diastolic blood pressures are more than 90mmHg and systolic ones are more than 140mmHg. 3.Person who has severe allergic disease as rhinitis, atopicdermatitis. 4.Person who is pregnant, lactating or planned to become pregnant during the test period. 5.Patient with vascular function disorder. 6.Person who has problems with electrocardiogram test such as arrhythmia. 7.Person who takes medicine. 8.Person who regularly goes to hospital or went to the medical institution within a month. 9.Current smoker. 10.Person who plans to participate in the other clinical studies. 11.Person who is judged as unsuitable for the study by the investigator for other reasons.
Target sample size	24

Research contact person
Name of lead principal investigator	Akane Suma
Organization	Kao Corporation
Division name	R&D-Skin Care Products Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	+81-3-5630-9581
Email	suma.akane@kao.com

Public contact
Name of contact person	Norio Shimizu
Organization	Kao Corporation
Division name	R&D-Skin Care Products Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	+81-465-35-3175
Homepage URL
Email	shimizu.norio@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	SOUKEN Co., Ltd.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 12 Month 07 Day
Anticipated trial start date	2018 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 18 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035249